On 3 December 2024, Merck, known as MSD outside the US and Canada, announced that sacituzumab tirumotecan (sac-TMT) has been granted Breakthrough Therapy designation by the FDA for advanced or metastatic NSCLC with epidermal growth factor receptor mutations whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy.
Sac-TMT is an antibody drug conjugate being developed by MSD in collaboration with Kelun Biotech, which has the commercialisation rights to sac-TMT in Mainland China, Hong Kong, Macau and Taiwan. MSD has a number of Phase 3 studies in progress evaluating sac-TMT as monotherapy, and in combination with Keytruda® (pembrolizumab), in solid tumours.
In November 2024, sac-TMT received its first marketing authorisation in China for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies.